NCT05610904

Brief Summary

Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
418

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 10, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

October 30, 2022

Last Update Submit

November 3, 2022

Conditions

Anastomotic Leak Rectum

Keywords

Anastomotic Leakrectal cancermachine learning

Outcome Measures

Primary Outcomes (1)

  • Accuracy of stoma implementation

    Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients.

    1 months after surgery

Secondary Outcomes (4)

  • Sensitivity and specificity in the prediction of anastomotic leakage

    1 months after surgery

  • Grade C leakage rate

    1 months after surgery

  • Preventive stoma rate

    1 months after surgery

  • Rate of stoma reverse

    3-6 months after surgery

Study Arms (2)

Surgeon evaluation

NO INTERVENTION

Surgeon combining with model evaluation

EXPERIMENTAL
Diagnostic Test: Prediction model evaluation

Interventions

Prediction model evaluationDIAGNOSTIC_TEST

a machine learning based anastomotic leakage prediction model

Surgeon combining with model evaluation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 years
  • Adenocarcinoma confirmed by pathology
  • Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal edge was less than or equal to 12cm
  • Preoperative imaging diagnosis was cTxNxM0
  • No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, and no invasion of adjacent organs)
  • The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia
  • Voluntarily sign the informed consent form

You may not qualify if:

  • Previous history of malignant tumor
  • Simultaneous multiple primary colorectal cancer
  • Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery
  • Patients with familial adenomatous polyposis and active inflammatory bowel disease
  • A history of severe mental illness
  • pregnant or lactating women
  • Patients with uncontrolled infection before operation
  • The investigator did not consider the patient to be eligible for the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Colorectal Surgery in Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Anastomotic LeakRectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 9, 2022

Study Start

December 10, 2022

Primary Completion

October 10, 2024

Study Completion

October 10, 2025

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

CN(1)